Webinar: FDA Annual Reporting Period for Drug Products

09.29.2017 | Posted by Daniel Henrich

In this webinar, you’ll get an overview of the FDA’s requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new submission type, the Blanket No Change Certification for drug product listings

WATCH NOW FOR:

High Level eRDL Requirements and History Overview

FDA Final Rule on eDRL (2016)

NEW No Change Certification Requirements for Drug Products (affects most drug product labelers and CMOs)